Devices, systems and methods for regulating flow from a stoma on a patient

ABSTRACT

A medical appliance is configured with material that creates a fluid barrier with interior walls of a stoma on a patient. These configurations may include an annular disc with a stem on one side that inserts into the stoma. The material may reside on the stem, for example, in the form of a replaceable hollow tube that covers at least part of the stem. On the other side, a rotatable spigot inserts into a recess. The rotatable spigot has a first position that forms a flow path through the stem and the annular disc to allow waste to drain from the stoma. In one implementation, the rotatable spigot can couple with a collection device that receives the waste. The patient can return the rotatable spigot to a second position to prevent flow of waste.

RELATED APPLICATION DATA

This application is a continuation-in-part of U.S. Nonprovisional patentapplication Ser. No. 16/254,453, filed on Jan. 22, 2019, and entitled“Regulating Flow From a Stoma on a Patient”, which claims priority toU.S. Provisional Patent Application No. 62/619,444, filed Jan. 19, 2018.This application also claims priority to U.S. Provisional PatentApplication No. 63/270,808, filed on Oct. 22, 2021, entitled “Devices,Systems and Methods for Regulating Flow From a Stoma on a Patient.” Eachof these applications is incorporated by reference herein in itsentirety.

FIELD OF THE DISCLOSURE

The present disclosure generally relates to the field of osteotomyappliances. In particular, the present disclosure is directed todevices, systems and methods for regulating flow from a stoma on apatient.

BACKGROUND

Surgical procedures often require post-operative access to a patient'sbody cavity to drain fluids or waste that may cause infection. A “stoma”is an example of one such type of surgically created access. In onecommon application a stoma is an opening to allow waste from thepatient's intestines to exit the body following colostomy or ileostomysurgery. The waste collects in a device, like a bag or pouch, thatattaches around the stoma or connects to the stoma via a drain tube.This conventional arrangement, while effective to allow drainage,typically affords the patient little control of waste as it drainsinvoluntarily into a collection device attached to the drain tube.Patients may elect to occlude the drain passage with, for example, aplug (in the stoma) or clamp (on the drain tube), however, discomfortmay result because the stoma is not meant to tolerate occlusion for longperiods of time. Damage to the drain tube may also allow waste to leakbefore the collection device.

SUMMARY OF THE DISCLOSURE

In one implementation, the present disclosure is directed to a stomavalve appliance, which includes an annular support member configured tosurround a patient stoma and having an inner, skin facing side and anouter side; a base member removably attachable over a center of theannular support member, the base member defining a first solids andliquids flow path and a second gas vent flow path through the basemember, each the flow path having at least one opening on an inner sideof the base member; a valve disposed in the base member configured tocontrol flow through the first flow path, the valve having an openposition permitting flow and a closed position preventing flow and beingmanipulable between the open and closed position by the patient; a stemwith an inlet and an outlet projecting inwardly from the body memberconfigured to be received in the patient stoma, the stem havingsufficient length to extend through the center of the annular supportmember to position the inlet in the stoma when the base member ismounted on the annular support member with the outlet at an opposite endcommunicating with the first flow path opening in the base member; and agas permeable filter seal around the stem covering the at least onesecond gas vent flow path opening, whereby gasses from the stoma may bevented through the second flow path, while liquids and solids areprevented from entering the second flow path.

In another implementation, the present disclosure is directed to apatient controllable method for evacuating waste from a stoma. Themethod includes positioning a vented valve appliance in the stoma. thevalve appliance having a closed position preventing waste from exitingthe stoma and an open position allowing waste to exit the stoma; thepatient selectively moving the valve appliance between the open andclosed positions to evacuate waste from the stoma or retain waste withinthe stoma for later evacuation; and continuously venting gasses from thestoma through the valve appliance in both the open and closed positions.

In yet another implementation, the present disclosure is directed to astoma valve appliance, which includes an annular support memberconfigured to surround a patient stoma and having an inner, skin facingside and an outer side; a skin adhesion layer disposed on the annularsupport member inner, skin facing side; a base member removablyattachable over a center of the annular support member, the base memberdefining a flow path through the base member, the flow path having anopening on an inner side of the base member; a valve disposed in thebase member configured to control flow through the flow path, the valvehaving an open position permitting flow and a closed position preventingflow and being manipulable between the open and closed position by thepatient; and an exit nozzle terminating the first path through the basemember opposite the inner side opening receiving flow thought the valvein the open position.

BRIEF DESCRIPTION OF THE DRAWINGS

For the purpose of illustrating the disclosure, the drawings showaspects of one or more embodiments of the disclosure. However, it shouldbe understood that the present disclosure is not limited to the precisearrangements and instrumentalities shown in the drawings, wherein:

FIG. 1 depicts a sketch of an exemplary embodiment of a valve appliancein position on a patient;

FIG. 2 depicts an elevation, side view of the valve appliance of FIG. 1;

FIG. 3 depicts the side view of the valve appliance of FIG. 1 , with thevalve appliance in a different configuration;

FIG. 4 depicts a perspective view from the top of an example of thevalve appliance of FIG. 1 ;

FIG. 5 depicts an elevation view from the side of the example of FIG. 4;

FIG. 6 depicts a plan view from the top of the example of FIG. 4 ;

FIG. 7 depicts a perspective view of an example of a spigot for use inthe example of FIG. 4 ;

FIG. 8 depicts a perspective view of an example of a tool for use withthe example of FIG. 4 ;

FIG. 9 depicts a perspective view of another example of the valveappliance of FIG. 1 ; and

FIG. 10 depicts a sketch of the example of FIG. 9 on a patient.

FIG. 11A is a perspective view of an embodiment of a valve appliance.

FIG. 11B is a front view of the embodiment of the valve appliance shownin FIG. 11A.

FIG. 11C is a cross-sectional view of the embodiment of the valveappliance shown in FIG. 11B through line A-A.

FIG. 12A is an exploded perspective view of the embodiment of the valveappliance shown in FIG. 11A.

FIG. 12B is an exploded cross-sectional view of the embodiment of thevalve appliance shown in FIG. 12A through line A-A (as shown in FIG.11B).

FIG. 13A is a front view of some of the components in a closedconfiguration of the embodiment of the valve appliance shown in FIG.11A.

FIG. 13B is a front view of some of the components in an openconfiguration of the embodiment of the valve appliance shown in FIG.11A.

FIG. 14 is a cross-sectional view of some of the components of theembodiment of the valve appliance of FIG. 11A in the open configurationof FIG. 13B through line A′-A′.

FIG. 15A is a front perspective view of an effluent capture device to beused with the embodiment of the valve appliance shown in FIG. 11A.

FIG. 15B is a rear perspective view of an effluent capture device shownin FIG. 15A.

FIG. 16 is a perspective view of an effluent capture device shown inFIG. 15A combined with the embodiment of the valve appliance shown inFIG. 11A.

FIG. 17 is a perspective view of some of the components of an effluentcapture device shown in FIG. 15A combined with some of the components ofthe embodiment of the valve appliance shown in FIG. 11A.

FIG. 18A is a perspective view of another embodiment of a valveappliance.

FIG. 18B is a front view of the embodiment of the valve appliance shownin FIG. 18A.

FIG. 18C is a cross-sectional view of the embodiment of the valveappliance shown in FIG. 18B through line B-B.

FIG. 18D is a cross-sectional view of the valve appliance as shown inFIGS. 18A and 18B with an alternative filter-seal arrangement.

FIG. 18E is a cross-sectional view of an alternative valve appliancesimilar to the embodiment shown in FIG. 18A, but with no stem or gasvent.

FIG. 19A is a front view of some of the components in a closedconfiguration of the embodiment of the valve appliance shown in FIG.18A.

FIG. 19B is a front view of some of the components in an openconfiguration of the embodiment of the valve appliance shown in FIG.18A.

FIG. 20A is a rear view of the alternate effluent capture device clip.

FIG. 20B is a side view of the alternate effluent capture device clipshown in FIG. 20A.

FIG. 21 is a perspective view of the valve appliance shown in FIG. 18Acombined with the alternate effluent capture device clip shown in FIGS.20A-B.

FIG. 22A is a perspective view of yet another embodiment of a valveappliance.

FIG. 22B is a front view of the embodiment of the valve appliance shownin FIG. 22A.

FIG. 22C is a cross-sectional view of the embodiment of the valveappliance shown in FIG. 22B through line C-C.

FIG. 22D is a cross-sectional view of the embodiment of the valveappliance shown in FIG. 22B through line D-D.

FIG. 22E is a cross-sectional view of the embodiment of the valveappliance shown in FIG. 22B through line E-E.

FIG. 23A is a perspective view of the embodiment of the valve applianceshown in FIG. 22A in an open configuration.

FIG. 23B is a front view of the embodiment of the valve appliance shownin FIG. 23A.

FIG. 23C is a cross-sectional view of the embodiment of the valveappliance shown in FIG. 23B through line F-F.

Where applicable, like-reference characters designate identical orcorresponding components and units throughout the several views (whichare not to scale unless otherwise indicated). The embodiments disclosedherein may include elements that appear in one or more of the severalviews or in combinations of the several views. Methods are exemplaryonly and may be modified by, for example, reordering, adding, removing,and/or altering the individual stages

DETAILED DESCRIPTION

The discussion that follows describes medical appliances that can engagewith surgically-formed stoma on a patient. These appliances allowpatients to periodically discharge waste from their bodies into a bag ora container for proper disposal. The designs proposed allow the patientto control flow in a convenient manner while remaining properly engagedwith the stoma to minimize leaks or other inadvertent discharge ofwaste.

FIG. 1 depicts a sketch diagram of an exemplary embodiment of a valveappliance 100. This embodiment is shown on a patient P, typically at alocation on patient P where access to a body cavity is necessary after asurgical procedure. This location may have a stoma, or port, whichallows waste to exit patient P into a collection device like a bag orpouch (not shown). The appliance 100 may include a support unit 102 thatreceives a spigot 104. A seal unit 106 may reside on part of the supportunit 102 to engage with the interior of the stoma.

The support unit 102 can be configured to provide access to dischargewaste from the patient's body. These configurations may embody deviceswith a flowpath that receives waste from the stoma. These devices mayhave a low-profile, preferably one that can be discretely worn under thepatient's clothing.

The spigot 104 can be configured to regulate waste discharge through theflowpath. These configurations may embody devices that can move (e.g.,rotate or translate) relative to the support unit 102. These devices mayinterface with the collection device. In use, the patient may couple thecollection device to an end of the spigot 104. The patient canmanipulate the spigot 104 to start flow of waste that discharges fromthe stoma into the collection device. When complete, the patient canmanipulate the spigot 104 to cease flow, remove the collection device,and return to their daily activities.

The seal unit 106 can be configured to seal the support unit 102 to thestoma. These configurations may embody devices made of materials that“self-seal” to create a fluid-tight or fluid-proof barrier betweensurfaces on both the device and the stoma. Preferably, the material doesnot require interaction with the patient to create this barrier.Exemplary materials may expand (in size or volume) inside of the stoma,for example, in response to contact with fluid (or other hydraulicinteractions). The material may also absorb fluids to prevent migrationof waste out of the patient's body. These features significantlysimplify use and maintenance because the patient can rapidly remove andreplace the material as part of their regular care or maintenance of theappliance 100.

FIG. 2 depicts a schematic diagram of an elevation view from the side ofan example of the valve appliance 100 of FIG. 1 . The support unit 102may include a body 110 with a proximal side 112 and a distal side 114.The proximal side 112 may contact patient P with the appliance 100 inposition at the stoma, shown and identified generally by the letter S. Astem 116 may extend from the proximal side 112. The stem 116 may form acylinder that inserts into the stoma. The cylinder may form integrallywith the body 110 as a single or monolithic piece. On the distal side114, the body 110 may have a recess 118 that forms a back surface 120. Athrough-bore 122 may extend from the back surface 120 through the body110 and the stem 116. The through-bore 122 creates a drain passage 124for waste to exit patent P through stoma S.

The spigot 104 may be configured to fit into the recess 118. Theseconfigurations may comprise an elongated body 126, itself with athrough-bore 128 that creates open ends (e.g., a first open end 130 anda second open end 132). The first open end 130 may insert into thecut-out recess 118, creating an articulating joint 134 with at least onedegree of freedom (identified here as rotation about an axis 136). Theaxis 136 may extend perpendicular to the drain passage 124. A snuginterference fit may be useful at the articulating joint 134 to retainthe elongate body 126 in the recess 118, but not frustrate rotationabout the axis 136. In use, the articulating joint 134 allows theelongated body 126 to change orientation relative to the body 110 toregulate flow of waste from stoma S. A first orientation for theelongated body 126 may align the through-bore 128 with the drain passage124, as shown in FIG. 2 . This orientation “opens” the appliance 100 topermit waste to flow into, for example, the collection device C thatcouples with the second open end 132 of the elongate body 126. As bestshown in FIG. 3 , rotation of the elongate body 126 to a secondorientation causes misalignment of the through-bore 128 and the drainpassage 124. This orientation “closes” the appliance 100 to block flowof waste out of stoma S. In this orientation, the elongate body 126 mayfit into the recess 118 for it to stow out of the way when not “open”for use with collection bag C.

The seal unit 106 may be configured to fit onto the cylinder of the stem116. These configurations may include a sleeve 138, for example, ahollow tube that can fit between the outer surface of the stem 116 andthe inner wall of stoma S. The hollow tube may cover all or part of thestem 116. Suitable materials may include cotton, rayon, or other“tampon-like” materials that can absorb moisture or expand in size orshape. These materials may be suitable along or in combination withother materials (e.g., synthetic fibers like viscose rayon). In oneimplementation, the tube of material may form an annular seal with theinner wall of the stoma. This annular seal may secure or hold theappliance 100 in place (possibly to foreclose the need for a belt). Itmay also prevent leaks of waste from patient P, for example, from aroundthe periphery of the stem 116. In one implementation, the sleeve 138 canbe configured to allow an end user to remove a first sleeve 138 ofmaterial from the stem 116 in favor of a second sleeve 138 of material.This second sleeve 138 of material may correspond with new material thatreplaces the soiled first sleeve 138 of material. This feature allowsthe end user to clean and sterilize the appliance 100, as well as tomaintain integrity (and cleanliness) of the sleeve 138 to avoidpotential infection or other issues that may arise due to prolongedexposure of the sleeve 138 inside of stoma S.

FIG. 4 depicts a perspective view of exemplary structure for the body110 for use in the valve appliance 100 of FIG. 1 . This structureincludes a disc portion 140 with an outer peripheral surface 142 thatcircumscribes an axis 144. The outer peripheral surface 142 may have anannular or circular shape, although other shapes, like a square, mayalso suffice. On the proximal side 112, the disc portion 140 may form aflat, planar surface 146, which as noted above may rest against patientP.

FIG. 5 shows an elevation view from the side of the example of FIG. 4 .The planar surface 146 may include a shallow recess 148, for example, acircular cut-out or groove that aligns with (or circumscribes) the axis144 and terminates at a bottom 150. Dimensions for the recess 148 maypermit at least part of the sleeve 138 to set into the material of thedisc portion 140. On the distal side 114, the body 110 may have a bossmember 152 that resides on the disc portion 140, opposite the stem 116.The boss member 152 may have an outer surface 154 with a first portion156 that is perpendicular or near-perpendicular with the axis 144. Thefirst portion 156 terminates at a second portion 158, which has agenerally domed or bulbous profile. This profile may flatten at top 160.

With reference also to FIG. 6 , which is a plan view of the distal side114 of the body 110, the recess 118 may have a first portion 162 thatexposes the drain passage 124. Geometry for the first portion 162 maymatch corresponding geometry of the elongated body 126 of the spigot104. The recess 118 may also have a second portion 164 that may extendradially outwardly from the first portion 162 to the perpendicularportion 156 of the outer surface 154. The second portion 164 may formopposite side walls 166 that are spaced apart from one another by a gapG. Examples of gap G are large enough to receive the elongated body 126of the spigot 104. In one implementation, the body 110 may include anaperture 168 that extends in a direction opposite of the recess 118.

FIG. 7 depicts a perspective view of an example of the elongated body126 of the spigot 104. This example may have a bulbous, rounded portion170 and a cylindrical portion 172. The rounded portion 170 may insertinto the first portion 162 of the recess 118. As noted above, the fitmay be snug, with appropriate tolerance interference to hold theelongated body 126 in position but still allow it to change orientationrelative to the boss member 152.

FIG. 8 depicts a perspective view of an example of a tool 174 for usewith the appliance 100. The tool 174 may have an elongated, cylindricalbody 176 that terminates at a locking feature 178. As shown, the lockingfeature 178 may form a chamfered head 180 that incorporates a slot 182.In use, the tool 174 may slide into the second open end 132 of theelongated body 126 and extend out the first open end 130. 126. In thisconfiguration the tool may prevent rotation of the spigot 104. In oneexample, the slot 182 may concomitantly engage with features on the body110 to prevent the tool 174 from “backing out” of the aperture 168.Pressing on the chamfered head 180 can disengage the slot 182 and allowan end user to withdraw the tool 174. This feature frees the spigot 104to move to its “open” orientation to allow waste to exit stoma S. Theend user may also utilize the tool 174 to clean out the drain passage124 to remove any waste that could block flow from stoma S.

FIG. 9 depicts a perspective view of another structure for the body 110for use in the valve appliance 100 of FIG. 1 . The planar surface 146may include a central bore 184 that penetrates into the material to forma bottom 186. An annular groove 188 may circumscribe the bore 184. Inone implementation, the seal unit 106 may include an O-ring or gasketthat fits into the annular groove 188. A thin membrane made ofcompliant, flexible material may be useful to interpose between theplanar surface 146 and patient P. These materials can prevent irritationof the skin of patient P under direct contact from the body 110 for longperiods of time. As best shown in FIG. 10 , a belt 190 may be requiredto secure the appliance 100 in place to allow patient P to carry on withdaily functions.

FIGS. 11A and 11B depict a further alternative embodiment of a valveappliance 200 configured to interface with a patient's stoma to allowpatient-controlled elimination of waste through the stoma. The valveappliance 200 is comprised of a base 202 that is attached to an adhesivewafer 206, which may be formed as a relatively thin, flexible annulardisk. The adhesive wafer 206 is configured with adhesive on the backside 212 for securing the valve appliance 200 to a patient's skin. Forexample, an adhesive surface 258 (FIG. 12B) on the adhesive wafer 206bonds the adhesive wafer 206 to the skin. Adhesive surface 258 can becomprised of any type of skin compatible adhesive such as a colloidalhydrogel adhesive. The adhesive wafer 206 can also include a removal tab219 used to assist the patient when they want to remove the adhesivebacked wafer from their skin and flex joints 203 that allow the adhesivewafer 206 to closely conform to the irregular contours of the patient'sskin. The base 202 has one or more bag clip engagement slots 213 a and213 b and one or more bag clip engagement tabs 217 a and 217 b. The bagclip engagement slots 213 a and 213 b and bag clip engagement tabs 217 aand 217 b are configured to hold a bag clip as will be described laterherein. The base 202 engages a gate valve 204 that sits on the front ofthe base 202. The gate valve 204 has a valve handle 205 on one end toenable the patient to open and close the gate valve 204 as will bedescribed later herein. The gate valve 204 is constrained to the base202 by a valve cover 207. The valve cover 207 and base 202 constrain thegate valve 204 but allow the gate valve 204 to slide open and closed aswill be described further herein. The valve cover 207 includes an exitnozzle 226 that guides effluent away from the valve appliance 200. Theexit nozzle 226 can be covered by a nozzle cap 208 when the patient isnot operating the valve appliance 200 to remove effluent. The nozzle cap208 is connected to the base portion 202 by means of a tether 211. Thetether 211 keeps the nozzle cap 208 connected to the valve appliance 200when the patient removes the nozzle cap 208 from the exit nozzle 226.

FIG. 11C depicts how the base portion 202 is engaged with the adhesivewafer 206 by a base clip 241 that engages with a wafer clip 243. Using abase clip 241 on the base portion 202 and wafer clip 243 on the adhesivewafer 206 allows the two parts to be connected and to separate asneeded. For example, the patient might want to attach the base 202 to asmaller diameter adhesive wafer 206 that conforms better to their skinthan the standard diameter adhesive wafer 206. Likewise, the patientmight want to attach the base portion 202 to an adhesive wafer 206 thathas a different type of adhesive that is more compatible with thepatient's skin. Compatibility of the adhesive to the patient's skin is avery important characteristic of the valve appliance 200 as the patientwill keep the valve appliance 200 attached to their skin for 2 or moredays before removing the valve appliance 200 to replace it with a newone. The adhesive wafer 206 is also comprised of an annular opening 218,and the base 202 is comprised of a domed cavity 214. The annular opening218 and domed cavity 214 are configured to cover the patient's stomathat often protrudes from the surface of the patient's skin withoutcompressing or otherwise impacting the stoma. It is important toaccommodate the stoma without irritating it by providing a cavitycomprised of the annular opening 218 and domed cavity 214. The patient'sstoma can change size and shape over time so allowing the patient tointerchange the adhesive wafer 206 for different sizes and/or adhesivetypes. Alternatively, in some embodiments, adhesive wafer 206 may beconfigured to allow the patient to trim the annular opening toaccommodate the patient's particular stoma size and shape. Similarly,the base 202 may be exchanged with other bases to provide a domed cavity214 to best match the stoma shape and size. The two-piece configurationdisclosed herein thus provides further advantages in patient comfortbased on the patient having the ability to control and change shapes andadhesion types over time without needing to replace the entire device.

The base clip 241 and wafer clip 243 are not the only possibleconfiguration for removably connecting the base 202 and adhesive wafer206. In one alternative, the base clip 241 and wafer clip 243 could bereplaced with interlocking threads allowing the base 202 and adhesivewafer 206 to be screwed together and screwed apart. If threads are usedrather than the base clip 241 and wafer clip 243 then a detent, latch,compression washer, or other restraining device may be required inaddition to the threads to prevent the threads from separating unlessintended. An arrangement of interlocking ribs and grooves, such as shownin FIG. 22D and described below, also may be used. Other removeableconnectors such as hook and loop fastening devices and other snap orinterference fit devices also may be employed.

The valve cover 207 is configured with an annular recess 223 that isconfigured to hold an annular seal 221. The annular seal 221 iscompressed against the valve cover 207 and the valve gate 204 to ensurethat no effluent leaks between the valve cover 207 and the valve gate204. The annular seal 221 could be an O-ring type seal. The annular seal221 could also be any other type of seal as are commonly used to preventfluid leakage between two parts. The annular seal 221 could also beadhesively or otherwise bonded to the valve cover 207 rather thancompressed against the valve cover 207. The annular seal 221 could alsobe molded onto the valve cover 207.

On the back side of the valve appliance 200 there is a stem 216 that iscovered by a gas permeable filter 238. The back end of the stem 216 hasan entry port 230 that allows effluent to enter the drain passage 228.As shown in FIG. 11C, the valve 204 is in the closed position and assuch is blocking the drain passage 228 and preventing effluent thatenter the drain passage 228 from exiting the patient's stoma. The gaspermeable filter 238 is configured to be compressed against the insidediameter of the stoma and prevent effluent from leaking between theouter surface of the gas permeable filter 238 and the stoma.

The front of the stem 216 is comprised of a slot 270 and a protrusion274 as depicted in FIG. 12B. The slot 270 is configured to interfacewith a ledge 272 on the base 202 and thereby connect the stem 216 to thebase 202. This connection between the slot 270 and the ledge 272 can bea simple overlapping connection. The connection can also includeadhesive or similar bonding between the slot 270 and the ledge 272. Thestem 216 could also be molded onto the base 202. The protrusion 274 isconfigured to seal against the backside of the gate valve 204 to preventeffluent in the drain passage 228 from leaking around the gate valve204.

Referring to FIG. 12A, the valve cover 207 is shown with a tether slot253 configured to receive and constrain a tether tab 251 on the end ofthe tether 211 opposite the nozzle cap 208. Although the tether slot 253is shown as part of the valve cover 207 it could also be configured tobe part of the base 202. A tether slot 253 and tether tab 251 are justone possible method for constraining the nozzle cap 208 and tether 211to the rest of the valve appliance 200. The tether 211 could beadhesively or otherwise bonded to the valve cover 207 or to the base202. The tether 211 could also be molded to the valve cover 207 or tothe base 202.

The base 202 is shown with a base opening 231 that is aligned with thedrain passage 228. The base opening 231 is also aligned with a valvecover opening 232 at the front end of the exit nozzle 226 on the valvecover 207. The gate valve 204 also has a gate opening 209. The entryport 230, drain passage 228, base opening 231 and valve cover opening232 are all aligned to allow effluent to exit through the valveappliance 100. However, in the configuration depicted in FIGS. 11A-C and12A-B, the gate opening 209 is not aligned with the entry port 230,drain passage 228, base opening 231 and valve cover opening 232 and thevalve appliance 200 is closed by the gate valve 204.

The valve cover 207 and nozzle cap 208 have been removed from FIGS. 13Aand 13B to facilitate the description of the operation of opening andclosing the valve appliance 200. In FIG. 13A, the gate valve 204 is inthe closed position and is substantially aligned with the base 202. Thegate valve is shown with cantilevered arms 263 a and 263 b that areformed by arm slots 265 a and 265 b. The ends of the cantilever arms 263a and 263 b have detents 261 a and 261 b. The detents 261 a and 261 bare constrained in closed pockets 267 a and 267 b formed in the base202. The detents 261 a and 261 b, and closed pockets 267 a and 267 b areconfigured to constrain the gate valve 204 relative to the base 202 andprevent the gate valve 204 from sliding unintentionally thereby keepingthe valve appliance 200 closed. When the patient wants to open the valveappliance 200, they pull the valve handle 205 in the direction shown byarrow “O” in FIG. 13B. When the pulling force of the detents 261 a and261 b against the closed pockets 267 a and 267 b is sufficient, thecantilever arms 263 a and 263 b will flex into the arm slots 255 a and265 b and the detents 261 a and 261 b will release from the closedpockets 267 a and 267 b. The gate valve 204 will then slide until thedetents 261 a and 261 b engage with the open pockets 269 a and 269 bthat are formed in the base 202. The cantilever arms 263 a and 263 bwill then spring back to hold the detents 261 a and 261 b in the openpockets 269 a and 269 b. In this open configuration the gate valve 204gate opening 209 is aligned with the entry port 230, drain passage 228,base opening 231 and valve cover opening 232 such that there is acomplete valve passage 278 as seen in FIG. 14 . The valve appliance 200is open in this configuration and effluent can exit the patient's body.When the patient is finished removing effluent, they apply a force tothe valve handle 205 in the direction opposite arrow “O” and slide thegate valve 204 back to the closed position. In this manner the patientcontrols the timing of effluent exiting their body.

When the effluent exits the valve cover opening 232, it is preferredthat the effluent be collected in a waste bag 280 such as shown in FIGS.15A and 15B, for example. The waste bag 280 is comprised of a pouch 282to hold the waste and a clip 284 to connect the waste bag 280 to a valveappliance such as valve appliance 200. The clip 284 is comprised of oneor more hooks 286 a and 286 b and one or more tabs 287 a and 287 b thatare configured to hold the waste bag 280 to the valve appliance 200. Theclip 284 also contains an opening 290 that is configured to engage withthe exit nozzle 226 to ensure that effluent coming out of the exitnozzle 226 goes into the pouch 282 and does not leak or spill. The clipcan also include a bag cap (plug) 288 that is connected to the clip by aflexible tether 289. The bag cap 288 can be used to seal the opening 290after the waste bag 280 has collected effluent from the valve appliance200 and the waste bag 280 is separated from the valve appliance 200. Theopening 290 can be configured with a seal to seal against the exitnozzle 226 or against the bag cap 288 to ensure effluent doesn't leak atthis connection.

FIG. 16 shows the waste bag 280 attached to the valve appliance 200 withthe valve appliance 200 in an open configuration to empty effluent fromthe patient through the valve appliance 200 and into the waste bag 280.In FIG. 17 the pouch 282 has been removed from the clip 284 to showdetails of how the waste bag 280 is connected to the valve appliance200. The one or more tabs 287 a and 287 b of the clip 284 are insertedinto the one or more bag clip engagement slots 213 a and 213 b on thebase 202 and the one or more hooks 286 a and 286 b of the clip 284 aresnapped over the one or more bag clip engagement tabs 217 a and 217 b.This secures the clip 284 and therefore the waste bag 280 to the valveappliance 200 and engages the waste bag 280 opening 290 with the exitnozzle 226. In use, the patient will first attach the waste bag 280 tothe valve appliance 200 before opening the gate valve 204 by pulling onthe valve handle 205. Then the effluent will flow through the open valveappliance 200 and into the waste bag 280. After all effluent has beenremoved through the patient's stoma, the patient will then push thevalve handle 205 to close the gate valve 204. After the valve appliance200 is closed, the patient will disengage the clip 284 and remove thewaste bag 280 from the valve appliance 200. Then the bag cap 288 can beplaced on the opening 290 of the waste bag to prevent effluent fromleaking. The nozzle cap 208 can also be placed over the exit nozzle 226of the valve appliance 200.

The base 202, gate valve 204, valve cover 207, and bag clip 284 can allbe fabricated from a rigid plastic resin such as, but not limited to,polypropylene, ABS, polycarbonate, and any blend of such materials.These parts also could be manufactured from metals like aluminum orstainless steel. The substrate portion of adhesive wafer 206 can befabricated from a flexible material such as, but not limited to,silicone, polyurethane foam or film, TPE (thermoplastic elastomer),polyethylene foam or film, PVC foam, nitrile rubber, and any blend ofsuch materials. The adhesive portion of adhesive wafer 206 can befabricated from either acrylic or synthetic rubber hydrocolloid adhesiveor other adhesives that are skin compatible. The stem 216 can befabricated from a flexible material such as, but not limited to,silicone, polyurethane, TPU, TPE, polyethylene. The stem 216 can befabricated from rigid or semi-rigid plastic resins such as but notlimited to polypropylene, abs, polycarbonate, and any blend of suchmaterials. The gas-permeable filter 238 can be fabricated from materialssuch as but not limited to such as polyester, rayon, acrylic,polyethylene, polypropylene, cotton, and blends of such. These materialscan natural hydrophobic properties or they can be treated with coatingssuch as but not limited to bifunctional polysiloxanes to achievehydrophobic performance. The annular seal 216 can be fabricated from aflexible or semi-rigid material such as put not limited to silicone,polyurethane, TPU, TPE, and other elastic materials. The waste bag 280can be fabricated from a flexible material such as but not limited topolyethylene, LDPE, HDPE, and other resin films.

In a further alternative embodiment, instead of pouch 282, clip 284 asdescribed above may be provided on a flexible discharge tube to allowthe patient to direct waste directly into a toilet. In anotheralternative, a flexible discharge tube may be provided with an outsidediameter at one end that is sized for a slight interference fit with theinside diameter of exit nozzle 226, whereby the discharge tube may besecurely inserted into the exit nozzle 226 when needed. Alternately, theinside diameter at one end of the discharge tube is sized for a slightinterference fit with the outside diameter of the exit nozzle 226 tosecure the discharge tube to the exit nozzle 226 to direct waste into atoilet. A flexible discharge tube of this type may be more convenientlycarried by a patient in situations where the patient has access toappropriate waste disposal facilities.

The description of the valve appliance 200 above is not intended toencompass all possible variations of valve appliances 200 covered bythis disclosure. Turning now to FIGS. 18A, 18B and 18C, an alternativeembodiment of a valve appliance 300 is shown. This valve appliance 300is comprised of a base 302, a valve gate 304, a valve cover 307, a seal321, a stem 316, and a filtration plate 340. The base 302 includes oneor more bag clip engagement tabs 317 a and 317 b, one or more bag clippockets 313, and one or more bag clip guides 315 a and 315 b to engage awaste bag clip 384 as will be described further herein. The base 302 isalso includes a plurality of vents 329 to vent gases through the valveappliance 300 as will be described further herein. The valve cover 307includes an exit port 332 to allow effluent to leave the valve appliance300. The seal 321 is located between the gate valve 304 and the valvecover 307 to ensure that effluent does not leak between the gate valve304 and the valve cover 307 (see FIG. 18C). The stem 316 has an entryport 330 to allow effluent to enter the drain passage 328 that passesthrough the center of the stem 316. The stem 316 can also seal againstthe gate valve 304 to ensure that effluent does not leak between thestem 316 and the gate valve 304.

The stem 316 is surrounded by a primary gas permeable filter 338 that isconfigured to be compressed against the inside diameter of the stoma andprevent effluent from leaking between the outer surface of the primarygas permeable filter 338 and the stoma. The stem 316 can also besurrounded by a secondary gas permeable filter 339 that is sandwichedbetween the stem 316 and the primary gas permeable filter 338. Thesecondary gas permeable filter 339 can be configured with finerfiltration than the primary gas permeable filter 338. Providing morethan one permeable filter can enable the valve appliance 300 to blocksolid material and more viscous liquid material with the primary gaspermeable filter 338 and block all remaining liquid with the secondarygas permeable filter 339 while allowing gas to pass through. The valveappliance 300 is not limited to just two layers of filters. Any numberof filter layers of varying filtration capabilities are possible. Havingmultiple layers of filtration capabilities allows liquid and solidmaterial to be blocked and gas to pass through without the liquid andsolid material clogging the first layer of filter.

It is important for the valve appliance 300 to allow the passage of gasso that the gas does not build up in the patient's digestive tract andcause uncomfortable pressure and sensations. The ability for the valveappliance 300 to release gas continuously while holding liquids andsolids until the patient chooses to remove that effluent helps reducethe frequency the patient operates the valve appliance to removeeffluent. Gas that passes through the primary gas permeable filter 338and the secondary gas permeable filter 339 is directed through one ormore entry ports 342 a-b in the filtration plate 340. The filtrationplate 340 is secured to the back side of the base 302 to form afiltration cavity 344 between the base 302 and the filtration plate 340.The filtration plate 340 can be secured to the base 302 with adhesivebonding or any other type of bonding such as ultrasonic welding. Thefiltration cavity 344 can be filled with an odor absorbing materialincluding but not limited to activated charcoal. The activated charcoalwill absorb odors from gases passing through the filtration cavitybefore the gasses exit the valve appliance 300 through the plurality ofexit ports 329. In this manner the valve appliance 300 can continuouslyrelease filter gases that do not have an unpleasant odor while allowingthe patient to choose when to open and close the valve appliance 300 toremove liquid and solid effluent.

In addition to providing a seal between the stem 316 and the patient'sstoma and a filter for gases, the gas permeable filter 338 also providesa soft interface between the stoma and the valve appliance 300. A softinterface is important to ensure that the valve appliance 300 that canbe worn in place for several days before removal and replacement doesnot irritate the stoma. In addition to covering the stem 316, thesecondary gas permeable filter 339, and the one or more entry ports 342a-b, the gas permeable filter 338 can also cover the outer surface ofthe filtration plate 340. In this manner the gas permeable filter 338can provide a soft interface between all the surfaces of the valveappliance 300 that are in contact with the patient's stoma. An alternatesoft material such as gauze dressing typically used on a wound couldalso be used to cover the outer surface of the filtration plate 340instead of the gas permeable filter 338 to provide a soft interfacebetween the valve appliance 300 and the patient's stoma. In a furtheralternative embodiment, illustrated in FIG. 18D, primary gas permeablefilter/seal 338 is configured as an annular disk filter/seal fittedaround stem 316. When configured as an annular disk filter/seal, primaryfilter/seal 338 may be a multi-layer structure wherein each layer isdesigned to filter a specific particle size. For example, a first innerlayer 338 a may have a filter pore size in the range of about 0.2-1.0millimeters (example materials include—polyurethane foam; metal mesh;vinyl mesh) in order to remove macroscopic solids, a second,intermediate layer 338 b may have a filter pore size in the range ofabout 10-50 microns (example materials include polypropylene or rayon)to capture microscopic solids, and third, outer layer 338 c may have afilter pore size in the range of about 0.2-0.5 microns (examplematerials include PTFE) to prevent liquids from entering entry ports 342a,b. In this manner filter plugging may be reduced, allowing gasses toescape while continuing to seal against liquid escape into filtrationcavity 344.

Valve appliance 300 may be attached to the patient using an annular diskattachment member such as adhesive wafer 206 as described above. Forthis purpose base 302 may be provided with annular base clip 341configured to engage wafer clip 243, as shown, for example, in FIG. 11C(where wafer clip 243 alternatively engages base clip 241 of base 202).Alternative means of patient attachment as described above also may beused. Base 302 is also preferably formed with an interior domed shape asshown, for example, in FIG. 18C, to accommodate the patient's stoma,which may protrude from the surrounding skin surface.

The valve cover 307 and seal 321 have been removed from FIGS. 19A and19B to illustrate the operation of the valve appliance 300. The valvegate 304 is comprised of a body 360, gate guides 351 a and 351 b oneither side of the body 360, cantilever arms 363 a and 363 b at one endof the body 360, and valve handles 305 a and 305 b on the ends of thecantilever arms 363 a and 363 b. The valve gate 304 is held constrainedin a closed position relative to the base 302 by lateral stops 361 a and361 b that project from the cantilever arms 363 a and 363 b that buttagainst stop ledges 367 a and 367 b on the base 302. To open the gatevalve 304, the patient squeezes the valve handles 305 a and 305 btowards each other and pulls the gate valve 304 in the direction of the“Arrow O′”. Squeezing the valve handles 305 a and 305 b towards eachother deflects cantilever arms 363 a and 363 b which in turn displacesthe lateral stops 361 a and 361 b such that they are free of the stopledges 367 a and 367 b. The gate guides 351 a and 351 b slide againstthe lateral sides 353 a and 353 b of the base slot 350 to keep the gatevalve moving in the direction of the Arrow O′ until the gate guides 351a and 351 b butt against the slot ledges 355 a and 355 b. When the gateguides 351 a and 351 b butt against the slot ledges 355 a and 355 b thegate opening 309 through the gate valve 304 is aligned with the drainpassage 328 and effluent can exit the patient. The patient can push thevalve handles 305 a and 305 b in the direction opposite Arrow O′ toclose the gate valve 304. Although the valve appliance 300 illustratedin FIGS. 18A through 19B only has one set of lateral stops 361 a and 361b and stop ledges 367 a and 367 b that hold the gate valve 304 lockeduntil the patient wants to open the valve appliance 300 to removeeffluent, the valve appliance 300 could also be comprised of another setof stops and ledges to hold the gate valve 304 open until the patientwanted to close the valve appliance 300. For example, the closed pockets267 a-b and the open pockets 269 a-b engaging the detents 261 a-b invalve appliance 200 illustrate locking the gate valve 200 in both closedand open positions.

In a further alternative, as illustrated in FIG. 18E, valve appliancesaccording to the present disclosure may be configured without a stem orgas vent. As one such example, alternative valve appliance 300A isstructured substantially the same as valve appliance 300, but withoutstem 316 and without the ports, filters and passages associated with thegas vent.

FIGS. 20A and 20B illustrate an alternative embodiment of a waste bagclip 384 with the pouch 282 that would be connected to the waste bagclip 384 not shown so as to highlight the features of the waste bag clip384. The waste bag clip 384 is comprised of one or more hooks 386 a and386 b and one or more tabs 387 that are configured to hold the waste bagclip 384 to the valve appliance 300. The waste bag clip 384 also has anopening 390 that is configured to engage with the exit port 332 of thevalve appliance 300 to ensure that effluent coming out of the exit port332 goes into the pouch 282 and does not leak or spill. The one or moretabs 387 have one or more guiding surfaces 389 a and 389 b configured toalign the one or more tabs 387 with the clip pocket 313 on the valveappliance 300 base 302 (See FIGS. 18A-C and 21). To attach the waste bagclip 384 to the base 302, the one or more tabs 387 of the waste bag clip384 is placed into the clip pocket 313 on the base 302. The guidingsurfaces 389 a and 389 b on the one or more tabs 387 interface with thesides 315 a and 315 b of the clip pocket 313 to facilitate the placementof the one or more tabs 387 into the clip pocket 313. The waste bag clip384 is then pushed against the base 302 until the one or more hooks 386a and 386 b of the waste bag clip 384 catch the one or more bag clipengagement tabs 317 a and 317 b on the base 302. Once the waste bag clip384 and with it the waste bag 28 is securely attached to the valveappliance 300, the patient can open the valve gate 304 to removeeffluent from their body. The valve appliance 300 or 200 can be usedwithout a waste bag clip to remove effluent from the body into a toiletof similar receptacle but use of the waste bag 280 can make the processeasier and cleaner for the patient.

The base 302, gate valve 304, valve cover 307, and bag clip 384, andfiltration plate 340 can all be fabricated from similar materials aswere described herein for the base 202, gate valve 204, valve cover 207,and bag clip 284 Similarly, the stem 316 can be fabricated from similarmaterials as were described herein for the stem 216. It is also to benoted that while stem 316 is shown in this example to be shorter thanthe stems of other embodiments, for example stem 216, stems of varyinglengths or no stem may be utilized with any of the disclosedembodiments. Where a stem is included, it may vary in length from havingan inner end lying approximately co-planar with the inside surface ofthe base to the longer stems shown in various embodiments. One factorbearing on stem length would be patient comfort. Specific vent designsalso may require longer or shorter stems.

FIGS. 22A-E illustrate another alternate embodiment of a valve appliance400. The valve appliance 400 is comprised of a base 402, an adhesivewafer 406, a ball valve 434, a valve lock 401, and a stem 416. The base402 is configured on the front side with a ball cavity 420 and a tubecavity 422. The ball cavity 420 is configured with two side slots 433a-b. The ball cavity is configured to accept the ball valve 434 and theside slots 433 a-b are configured to accept the ball axels 435 a-b. Theball valve 434 pivots relative to the base 402 around the axis formed bythe ball axels 435 a-b. The base is also comprised of one or more filtercavities 453 a-b. The one or more filter cavities 453 a-b are coveredwith one or more filter cavity covers 452 a-b. The one or more filtercavity covers 452 a-b contain order absorbing material inside the one ormore filter cavities 453 a-b. The one or more filter cavity covers 452a-b can be attached to the base 402 with adhesive bonding or any othertype of bonding including ultrasonic welding, solvent bonding, insertmolding, and the like. The one or more filter cavity covers 452 a-bcontain a plurality of openings 454 to allow gases to pass through theodor absorbing material in the one or more filter cavities 453 a-b andout of the valve appliance 400. The base 402 is configured on the backside with one or more ribs 494 that interface with one or more grooves492 on the adhesive wafer to securely attach the base 402 to theadhesive wafer 406. The ribs 494 and grooves 492 can be attached withadhesive bonding or any other type of bonding including ultrasonicwelding, solvent bonding, insert molding, and the like.

The adhesive wafer 406 is comprised of one or more grooves 427. The oneor more grooves 427 can be on either the front surface or the backsurface of the adhesive wafer 406 and provide for a more flexibleadhesive wafer 406 to optimize the adhesive wafer's 406 conformation andadherence to the patient's skin. The back side of the adhesive wafer 405is comprised of a skin compatible adhesive to ensure the valve appliance400 can be adhered to the patient's skin for several days to keep thevalve appliance 400 in position without irritating the patient's skin.

The ball valve 434 is also comprised of an exit nozzle 404 at the end ofwhich is the exit port 415. The ball valve 434 also has a bottom port418 which is in communication with the exit port 516 by means of anozzle passage 417 (See FIG. 23C).

The valve lock 401 is comprised of an elongated rod 403 with an end face413 at one end and a lock handle 405 at the other end. The valve lock401 also has a wiping edge 425 adjacent to the end face 413. Theelongated rod 403 fits in the nozzle passage 417 of the ball valve 434with the wiping edge 425 extending past the exit nozzle 404. The outerdiameter of the wiping edge 425 is greater than the inside diameter ofthe nozzle passage 417 and thereby holds the valve lock 401 inside theball valve 434 with the valve lock 401 preventing the ball valve 434from rotating thereby locking the ball valve 434 and keeping the valveappliance 400 closed. The valve lock 401 also has a guide channel 410with a guide stop 414 near the end face 413. The guide channel isconfigured to slide over a stop boss 412 on the base 402. When the valvelock 401 is actuated as will be described further herein, the stop boss412 prevents the valve lock 401 from rotating, and the guide stop 414prevents the valve lock 401 from being separated from the valveappliance 400.

The stem 416 is attached to the base 402 and is covered by a gaspermeable filter 438. The back end of the stem 416 has an entry port 430that allows effluent to enter the drain passage 428. The front end ofthe stem 416 is compressed against the ball valve 434 to preventeffluent from leaking from the stem when the valve appliance 400 is inthe locked position. The gas permeable filter 438 is comprised of one ormore wicks 439 that pass-through slots 440 in the base 402 to the one ormore filter cavities 453 a-b.

FIGS. 23A, 23B and 23C show the valve appliance 400 in an open position.To open the valve appliance 400, the patient first holds the lock handle405 and slides the valve lock 401 in the direction of Arrow O″. Thisaction pulls the wiper edge 425 into the exit port 415 and through thenozzle passage 417 of the ball valve 434. When the valve lock 401 iscompletely withdrawn from the ball valve 434, the guide stop 414contacts the stop boss 412 of the base 402 preventing additionaltranslation of the valve lock 401. The patient then holds the exitnozzle 404 of the ball valve 434 and pivots the ball valve 434 about theaxis formed by the ball axels 435 a-b. This moves the ball valve 434from the horizontal locked position to a vertical open position. In thisopen position, there is a continuous opening created starting from theentry port 430 on the end of the stem 416, through the drain passage 428in the stem 416, to the bottom port 418 on the ball valve 434, throughthe nozzle passage 417 in the exit nozzle 404, and ending at the exitport 415. In this manner effluent can enter the valve appliance 400through the entry port 430 and leave through the exit port 415 and thepatient can remove effluent from their body.

After removing all effluent, the patient can rotate the ball valve 434back to a horizontal position closing the valve appliance 400. Then thepatient can slide the valve lock 401 back into the ball valve 434. Thewiper edge 425 is pushed into the bottom port 418, through the nozzlepassage 417 in the exit nozzle 404, and out the exit port 415. Thisactuation of the valve lock 401 with the wiper edge 425 near the endface 413 cleans out any effluent that may be still present in the nozzlepassage 417 so that the ball valve 434 is clean until the next time thepatient wants to actuate and open the valve appliance 400.

The base 402, ball valve 404, cavity covers 452 a-b, and valve lock 401,can all be fabricated from similar materials as were described hereinfor the base 202, gate valve 204, and valve cover 207. Similarly, thewafer 406, the stem 416, gas permeable filter 438, and wiping edge 425can be fabricated from similar materials as were described herein forthe wafer 206 and the stem 216, gas permeable filter 238, and annularseal 221, respectively.

In further alternative embodiments, valve appliances may be configuredsubstantially as described hereinabove, but without a gas vent. The needfor gas venting in some cases may be correlated to patient personalhabits such as frequency of evacuation and diet. Patients that do notrequire a gas vent may therefore prefer the greater control that couldbe afforded by a ventless valve appliance. Further, in some embodimentsit may be preferable to not include the stem component while otherwiseconfiguring valve appliance embodiments in accordance with theembodiments described herein. Removal of the stem component for somepatients may increase comfort of the device. Additionally, as onepurpose of the stem in some embodiments is to create functionallyseparate pathways for evacuation of gas versus liquid/solid wastes, itmay be desirable to omit the stem component in unvented embodiments.

In view of the foregoing, the improvements discussed herein canfacilitate discharge of waste from stoma. The embodiments employmaterials that self-seal with surfaces inside of the patient's body.This feature eliminates the need for the patient to interact with thedevice to properly affix it in position so as to avoid leaks or otherpotential mistakes that can allow waste to inadvertently discharge fromthe stoma.

The foregoing has been a detailed description of illustrativeembodiments of the disclosure. It is noted that in the presentspecification and claims appended hereto, conjunctive language such asis used in the phrases “at least one of X, Y and Z” and “one or more ofX, Y, and Z,” unless specifically stated or indicated otherwise, shallbe taken to mean that each item in the conjunctive list can be presentin any number exclusive of every other item in the list or in any numberin combination with any or all other item(s) in the conjunctive list,each of which may also be present in any number. Applying this generalrule, the conjunctive phrases in the foregoing examples in which theconjunctive list consists of X, Y, and Z shall each encompass: one ormore of X; one or more of Y; one or more of Z; one or more of X and oneor more of Y; one or more of Y and one or more of Z; one or more of Xand one or more of Z; and one or more of X, one or more of Y and one ormore of Z.

Various modifications and additions can be made without departing fromthe spirit and scope of this disclosure. Features of each of the variousembodiments described above may be combined with features of otherdescribed embodiments as appropriate in order to provide a multiplicityof feature combinations in associated new embodiments. Furthermore,while the foregoing describes a number of separate embodiments, what hasbeen described herein is merely illustrative of the application of theprinciples of the present disclosure. Additionally, although particularmethods herein may be illustrated and/or described as being performed ina specific order, the ordering is highly variable within ordinary skillto achieve aspects of the present disclosure. Accordingly, thisdescription is meant to be taken only by way of example, and not tootherwise limit the scope of this disclosure.

Exemplary embodiments have been disclosed above and illustrated in theaccompanying drawings. It will be understood by those skilled in the artthat various changes, omissions and additions may be made to that whichis specifically disclosed herein without departing from the spirit andscope of the present disclosure.

What is claimed is:
 1. A stoma valve appliance, comprising: an annularsupport member configured to surround a patient stoma and having aninner, skin facing side, outer side and a central opening; a base memberremovably attachable over a center of the annular support member, saidbase member defining a first solids and liquids flow path and a secondgas vent flow path through the base member, each of the first and secondflow paths having at least one opening on an inner side of the basemember; a valve disposed in the base member configured to control flowthrough said first flow path, the valve having an open positionpermitting flow and a closed position preventing flow and beingmanipulable between the open and closed positions by the patient; a stemwith an inlet and an outlet, the stem projecting inwardly from the basemember through the central opening of the annular support member, thestem having sufficient length to extend from the central opening of theannular support member to position the inlet in the stoma when the basemember is mounted on the annular support member whereby the outlet at anopposite end of the stem is configured for communicating with the firstflow path opening in the base member; and a gas permeable filter sealpositioned around the stem and extending to and covering the at leastone second gas vent flow path opening, whereby gasses from the stoma canbe vented from the stoma through said gas permeable filter seal and saidsecond flow path, while liquids and solids from the stoma are preventedfrom entering said second flow path.
 2. The stoma valve appliance ofclaim 1, wherein the base member has an inwardly facing concave surfaceshaped to accommodate the patient stoma protruding through the center ofthe annular support member.
 3. The stoma valve appliance of claim 1,further comprising an adhesive layer configured to secure the annularsupport member to the patient's skin, wherein the adhesive layer isdisposed on the inner skin facing side of the annular support member. 4.The stoma valve appliance of claim 3, wherein the adhesive layercomprises a flexible, annular disk of adhesive material.
 5. The stomavalve appliance of claim 1, wherein the gas permeable filter sealfurther comprises an annular disk filter member having said plurallayers through which the stem extends.
 6. The stoma valve appliance ofclaim 1, wherein the annular support member and base member are attachedby being pressed together.
 7. The stoma valve appliance of claim 6,wherein the annular support member and base member each have facingengagement surfaces that engage and fix said members together whenpressed together.
 8. The stoma valve appliance of claim 7, where saidfacing engagement surfaces are resilient hook shapes.
 9. The stoma valveappliance of claim 7, wherein said facing engagement surfaces compriseinterlocking ribs and grooves.
 10. The stoma valve appliance of claim 1,further comprising an exit nozzle terminating the first flow paththrough the base member opposite the inner side opening.
 11. The stomavalve appliance of claim 10, further comprising: a waste collection bag,wherein the waste collection bag comprises—a pouch; a connector sealedto the pouch having an opening configured to mate with the exit nozzleto receive solids and liquids therefrom; and first engagement meansdisposed on the connector; and second engagement means disposed on thebase member configured to engage said first engagement means to securethe waste collection bag to the base member with the exit nozzle matedto the connector opening.
 12. The stoma valve appliance of claim 1,wherein the valve is a gate valve.
 13. The stoma valve appliance ofclaim 12, wherein the gate valve comprises a valve gate slidably mountedin the base member.
 14. The stoma valve appliance of claim 13, whereinthe valve gate includes a detent locking mechanism engageable with thebase member to lock the valve gate in the closed position.
 15. The stomavalve appliance of claim 14, wherein the detent locking mechanism formsa user manipulable handle on the valve gate.